ABSTRACT
The Optic Neuritis Treatment Trial (ONTT) was an investigator-initiated, multi-centered, randomized, controlled clinical trial supported by cooperative agreements and grants. It was designed to evaluate the efficacy and safety of oral prednisone or intravenous methylprednisolone followed by oral prednisone as compared with oral placebo. The primary outcome measures were contrast sensitivity and visual field; secondary measures were visual acuity and color vision. Four hundred fifty-seven patients were followed for a minimum of 6 months and a maximum of 3 years. This article describes the design and the methods used to implement the ONTT.
Subject(s)
Optic Nerve/physiopathology , Optic Neuritis/physiopathology , Adolescent , Adult , Female , Humans , Male , Methylprednisolone/administration & dosage , Methylprednisolone/therapeutic use , Middle Aged , Optic Neuritis/complications , Optic Neuritis/drug therapy , Placebos/administration & dosage , Placebos/therapeutic use , Prednisone/administration & dosage , Prednisone/therapeutic use , Treatment Outcome , Vision Disorders/complications , Vision Disorders/drug therapy , Vision Disorders/physiopathologyABSTRACT
In order to determine the effects on plasma lipoproteins of oral contraceptives containing progestins with varying androgenic potency, 136 healthy women were randomized into 3 groups and followed prospectively for one year while receiving either 50 mcg ethinyl estradiol and 1.0 mg ethynodiol diacetate (EED), 50 mcg ethinyl estradiol and 1.0 mg norethindrone acetate (ENA), or 50 mcg ethinyl estradiol and 0.5 mg d-1 norgestrel (ENG). Comparison was made to a self-selected group of 50 women using alternative means of contraception. Plasma cholesterol increased by 7-9% and triglycerides by 32-57% in all 3 groups (p less than 0.05). ENG use resulted in other significant lipoprotein changes including an 18% increase in low density lipoprotein cholesterol (LDL-C), a 13% fall in high density lipoprotein cholesterol (HDL-C) and a 27% decline in HDL2 cholesterol (HDL2-C) (p less than 0.05). Apoprotein A-I (Apo A-I) increased by 9% with ENA and by 11% with EED (p less than 0.05), but did not change significantly with ENG. This prospective study demonstrates that in oral contraceptive agents with identical estrogen, progestins with different androgenic potency produce major and different changes in plasma lipoproteins.
PIP: In order to determine the effects on plasma lipoproteins of oral contraceptives containing progestins with varying androgenic potency, 136 healthy women were randomized into 3 groups and followed prospectively for 1 year while receiving either 50 mcg ethinyl estradiol and 1.0 mg ethynodiol diacetate (EED), 50 mcg ethinyl estradiol and 1.0 mg norethindrone acetate (ENA), or 50 mcg ethinyl estradiol and 0.5 mg d-1 norgestrel (ENG). Comparison was made to a self-selected group of 50 women using alternative means of contraception. Plasma cholesterol increased by 7-9% and triglycerides by 32-57% in all 3 groups. ENG use resulted in other significant lipoprotein changes including an 18% increase in low density lipoprotein cholesterol, a 13% fall in high density lipoprotein cholesterol and a 27% decline in high density lipoprotein-2 cholesterol. Apoprotein A-1 increased by 9% with ENA and by 11% with EED, but did not change significantly with ENG. Khis prospective study demonstrates that in oral contraceptive agents with identical estrogen, progestins with different androgenic potency produce major and different changes in plasms lipoproteins.